Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed April 27, 2026 has been entered. Claims 1-10 remain pending in the application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 10,912,866) in view of Hollar et al. (US 2017/0232640).
Regrinding claims 1-3, Zhang discloses that, as illustrated in Figs. 1, 2, in Example 1 (col. 9, lines 50-67 and col. 10, lines 1-43), the mixed powder including PEEK powder (one type of PAEK (polyaryletherketone) (related to claim 3)) having a grain size of 70 micron was prepared (col. 9, lines 60-67). In the pressing mold as illustrated in Fig. 2, the pure PEEK powder is poured into the bottom of the mould to be used as the inner sense layer, the loose layer mixed powder material is placed in the middle of the mould, then a layer of pure PEEK powder is paved on an upper layer to be used as the outer dense layer (col. 10, lines 1-6). The cold pressed mould is placed on a high-temperature oven or an external heating device for melting and heating the material at a heating temperature of 390 C (col. 10, lines 15-17).
It is noticed that, during the heating process, the pressing core bar 4 and the mould barrel 5 play a function of the contacting heaters (or heating elements) to the multiple layers of powders inside the press mold. Because of the different porosities of the first porous section (i.e., the inner dense layer) and the second porous section (i.e., the loose middle layer), heat transfer for the thermal bonding inside the different layers of the powder bed is inhomogeneous (related to claim 2).
It is also noticed that, either the pure PEEK powder for the inner/upper layer or the loose layer mixed powder for the middle layer are defined as the granular material.
However, Zhang does not disclose how the powders in the mixture are produced.
In the same field of endeavor, polymer powders, Hollar discloses that, as illustrated in Fig. 2, the polymer powder feed 12 is fed from feed hopper 14 to a gap between a pair of cooperatively rotating compaction rolls 16, 18 ([0017], lines 1-6). Compaction rolls 16, 18 compact the polymer and cause then to coalesce into densified polymer material 20, which emerges from the gap ([0017], lines 11-13). The temperature of the compaction rolls can be 0 to 270 C ([0021], lines 12-13). Polymer material 20 is then granulated in granulator 24 to form densified polymer powder 22 ([0017], lines 1-2 from bottom). Here, the densified polymer material 20 can be considered as one intermediate piece produce through heating and pressing.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhang to incorporate the teachings of Hollar to provide the densified granular polymer powder. Doing so would be possible to improve the production of the biocompatible implant such as costs, as recognized by Hollar ([0002]).
Regarding claims 4, 5, 7, Zhang discloses that, PEEK powder having a grain size of 70 micron (col. 9, lines 62-63) (in the range of a particle size of between 1 micron to 3000 micron in claim 7). Here, the grain size of 70 micron defines at least the average diameter of the PEEK powders in which the cross section of each particle has a round shape.
During the manufacturing process of the polymer powder in the teachings of Hollar, the densified polymer powder can be screened to produce powders with narrow particle size distributions. The screen can have openings that can be spherical, elliptical, hexagonal, triangular, and the like. The openings can have an area, where a circle if the same area can have a diameter less or equal to 10 mm, …. ([0027]). Thus, Hollar discloses that, at least the granular material comprises particles having a round cross section (related to claims 4, 5).
It would have been obvious to use the method of Zhang to have the polymer powder as Hollar teaches that it is known to have the granular material comprises particles having a round cross section. It has been held that the combination of known technique to improve similar method is likely to be obvious when it does not more than yield predictable results to one of ordinary skill in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Regarding claim 6, Zhang discloses that, in the above porous bionic skull repairing material, the inner dense layer and the outer dense layer are made of polymer material, or a mixture of a polymer material and a bioactive substance (col. 3, lines 25-28).
Regarding claim 8, Zhang discloses that, during the preparation of a cold pressed sheet, the pure PEEK powder is poured into the bottom of the mould to be used as the inner dense layer, the loose layer mixed powder material is placed in the middle of the mould (col. 10, lines 1-4). Thus, at least Zhang discloses that the mold is filled with a plurality of granular materials differing with respect to their particle size or particle shape before the thermal bonding of the granular material.
Regarding claim 9, Zhang discloses that, during the hot pressing, the mould in which the material is completely molten is quickly placed into a hydraulic machine for hot pressing, with a maximal set pressure of 15 MPa (col. 10, lines 20-23).
Regarding claim 10, Zhang discloses that, as illustrated in Fig. 2 (especially for press molding), the mold comprises a shaping means which forms a cavity within the implant body during the thermal bonding of the granular material (col. 9, lines 21-22 and lines 32-37).
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered. They are not persuasive.
In response to applicant’s arguments (as amended) in claim 1 that Zhang in view of Hollar fails to disclose an implant body having at least one first porous section and one second porous section formed from a granular material and essentially, in the teachings of Zhang, separate powders formed from different materials are used to form the layers with different densities, it is not persuasive.
Basically, a granular material is a broad concept in Applicant’s claim 1. For example, in claim 1, lines 5-6, a granular material is open for how to impart it, such as comminuting one intermediate piece or two intermediate pieces etc. As illustrated in Fig. 2 of Applicant, two granular materials G1, G2 are filled into the mold 20 ([0060], lines 1-2). At least, as demonstrated in Fig. 2 of Applicant, granular material G1 has a smaller diameter than granular material G2.
It is also noticed that, in the teachings of Zhang, either the pure PEEK powder for the inner/upper layer or the loose layer mixed powder for the middle layer are defined as the granular material.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shibin Liang whose telephone number is (571)272-8811. The examiner can normally be reached on M-F 8:30 - 4:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alison L Hindenlang can be reached on (571)270 7001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIBIN LIANG/Examiner, Art Unit 1741
/ALISON L HINDENLANG/Supervisory Patent Examiner, Art Unit 1741
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